Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-04 @ 8:33 AM
Study NCT ID:
NCT02607592
Status:
UNKNOWN
Last Update Posted:
2022-02-25
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Multi-center Phase III Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 293}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2015-11-17', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free-survival（PFS）', 'timeFrame': '12months', 'description': 'Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first'}], 'secondaryOutcomes': [{'measure': 'objective response rate （ORR）', 'timeFrame': '12months', 'description': 'ORR is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).'}, {'measure': 'overall survival（OS）', 'timeFrame': '24 months', 'description': 'OS is defined as the time from the starting date of study drug to the date of death due to any cause'}, {'measure': 'overall toxicity value', 'timeFrame': '12 months', 'description': 'toxicity graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0'}, {'measure': 'Progression-Free Survival (PFS) rate at 18 weeks', 'timeFrame': '20 weeks', 'description': 'the proportion (%) of patients without disease progression at 18 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non-Small-Cell Lung cancer', 'overall toxicity value'], 'conditions': ['Carcinoma，Non-Small-Cell Lung']}, 'referencesModule': {'references': [{'pmid': '14691125', 'type': 'RESULT', 'citation': 'Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR; American Society of Clinical Oncology. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol. 2004 Jan 15;22(2):330-53. doi: 10.1200/JCO.2004.09.053. Epub 2003 Dec 22. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the PFS, ORR, OS and overall toxicity value（OTV）on advanced adenocarcinoma treated with nedaplatin or cisplatin combined with pemetrexed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient who was confirmed primary adenocarcinoma by pathologic histology or cytology\n2. The TNM staging system according to IASLC2009 was stageIV or those stageIIIB who were not fit for operation or radiotherapy\n3. Including one available evaluation lesion at least according to RECIST criteria\n4. Adult patients (≥18 years and ≤75 years). ECOG Performance Status 0 or 1 .Life expectancy of at least 12 weeks.Haemoglobin ≥90g/dl, Absolute neutrophil count (ANC)≥ 2x 109/L, platelets ≥100 x 109/L. Total bilirubin ≤upper limit of normal (ULN). ALT and AST ≤ 2.5 x ULN. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula).\n5. Patients who had never received any antineoplastic therapy\n\nExclusion Criteria:\n\n1. Patient who has another cancer in recent 5 years,not including basal cell carcinoma or cervical carcinoma in situ\n2. Patient with brain metastases whose intracranial pressure symptoms can not control by using glucocorticoid or mannitol\n3. Previous radiotherapy（Palliative radiotherapy in order to pain management can be excluded）\n4. Patient who has used chemotherapy before(bisphosphonate can be excluded )\n5. Serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease\n6. Patient who is allergic to drugs we need to use\n7. Patients who are in pregnancy or lactation\n8. AST or ALT 》2.5 \\* upper limit of normal (ULN)，and ALP》5\\*ULN'}, 'identificationModule': {'nctId': 'NCT02607592', 'acronym': 'NACA', 'briefTitle': 'A Prospective Multi-center Phase III Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Nedaplatin or Cisplatin Combined With Pemetrexed in the First Line Treatment of Advanced Adenocarcinoma：A Prospective Multi-center Phase III Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '201507003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nedaplatin and Pemetrexed', 'description': 'nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）', 'interventionNames': ['Drug: nedaplatin+pemetrexed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cisplatin and Pemetrexed', 'description': 'cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）', 'interventionNames': ['Drug: cisplatin and pemetrexed']}], 'interventions': [{'name': 'cisplatin and pemetrexed', 'type': 'DRUG', 'description': 'cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）', 'armGroupLabels': ['Cisplatin and Pemetrexed']}, {'name': 'nedaplatin+pemetrexed', 'type': 'DRUG', 'description': 'nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）', 'armGroupLabels': ['Nedaplatin and Pemetrexed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'li-kun chen, doctor', 'role': 'CONTACT', 'phone': '13798019964'}], 'facility': 'Sun Yat-sen University of cancer center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'li-kun chen, Doctor', 'role': 'CONTACT', 'email': 'chenlk@sysucc.org.cn', 'phone': '13798019964'}], 'overallOfficials': [{'name': 'li-kun Chen, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Li-kun Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}